Clinical TrialSuicidalityKetamineRecruiting

Feasibility and Safety of Ketamine for Suicidal Patients in the Emergency Department

This interventional trial (n=50) conducted by the University of Kansas Medical Center will assess the feasibility and safety of administering a single dose of ketamine to acutely suicidal patients in the Emergency Department.

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Target Enrollment
50 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

Phase I single-group study to evaluate safety and feasibility of a single low-dose IV ketamine (0.2 mg/kg) given to acutely suicidal ED patients; primary outcomes are safety and feasibility metrics.

Participants are observed in the ED for 2 hours post-dose, then transferred for inpatient psychiatric care; depressive and suicidal symptoms are assessed at 0, 2 hours, 24 hours and 72 hours alongside ED staff feasibility surveys.

Study Protocol

Preparation

sessions

Dosing

1 sessions
120 min each

Integration

sessions

Study Arms & Interventions

Ketamine IV

experimental

Single low-dose IV ketamine (0.2 mg/kg) administered in the ED to acutely suicidal patients; single-group feasibility/safety design.

Interventions

  • Ketamine0.2 mg/kg
    via IV• single dose• 1 doses total

    Observed in ED for 2 hours then transferred to psychiatric admission as per standard care; assessments at 0, 2h, 24h, 72h.

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Acutely Suicidality ("yes" answer to any of items 4 or 5 on C-SSRS "Suicidal Ideation" category)
  • Require inpatient stabilization for SI or actions based on clinical observation and interview
  • Are accepted for psychiatric stabilization at the University of Kansas Medical Center's Strawberry Hill campus
  • Have a Glasgow Coma Score (GCS) of 15
  • Age 18-65

Exclusion Criteria

  • Exclusion Criteria:
  • Current or past history of psychosis
  • Current or recent (past 4 weeks) symptoms of mania/hypomania as defined by Young Mania Rating Scale (YMRS) score of 12 or greater
  • History of ketamine use disorder
  • History of liver transplant
  • Pregnancy or breastfeeding
  • Imprisonment or inability to consent
  • Positive urine drug screen or serum alcohol level
  • Hypertension (SBP > 160 or DBP > 100 before administration of ketamine)
  • Hypotension (SBP < 90)
  • Presence of acute medical condition requiring admission to medical service
  • Allergy, intolerance, or previous adverse reaction to ketamine
  • Patient has 8+ lifetime ketamine exposures
  • The treating physician determines that the patient is not a good candidate for the study (e.g. medical condition/procedure, medication that would contraindicate ketamine treatment)

Study Protocol, Arms & Participants

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Study Details

  • Status
    Recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment50 participants
  • Timeline
    Start: 2023-12-01
    End: 2024-12-31
  • Compound
    Ketamine
  • Topic
    Suicidality

Locations

University of Kansas Strawberry Hill Campus — Kansas City, Kansas, United States
University of Kansas Medical Center Emergency Department — Kansas City, Kansas, United States

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